← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K964340 # PORTAREM-3000, PFS-6000 (K964340) _Starkey Laboratories, Inc. · EWO · Jan 10, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K964340 ## Device Facts - **Applicant:** Starkey Laboratories, Inc. - **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md) - **Decision Date:** Jan 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.1050 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Indications for Use The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other options described in the user manual are available. ## Device Story Portable hearing aid dispensing system for clinical use by hearing health care professionals. Inputs: probe microphone signals (Real Ear/In Situ), puretone audiometry, and hearing aid test chamber measurements. System performs IEC/ANSI standard testing, intermodulation distortion analysis, and 2cc coupler conversions. PFS software provides prescriptive fitting formulas (NAL, POGO I/II, 1/2 Gain, 1/3 Gain, Berger), matrix selection, and order printing. Output: visual data on 4.7" LCD/external monitor, hard copy via built-in thermoprinter, and hearing aid performance metrics. Benefits: enables precise hearing aid calibration, fitting, and verification of performance against prescriptive targets. ## Clinical Evidence Bench testing only; system complies with IEC 601 and FCC Part 15 Class B standards. No clinical trial data provided. ## Technological Characteristics 2-channel system; 4.7" 640x480 color LCD; built-in thermoprinter; 3.5" floppy drive; 2x RS-232 ports; 6W loudspeaker (50-15,000 Hz). Measurement range: 42-15,600 Hz; dynamic range 130 dB; accuracy ±0.2 dB. Electrical THD < 0.01%. Power: 110/220V AC. Complies with IEC 601 and FCC Part 15 Class B. ## Regulatory Identification An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JAN 10 1997 K964340 # SAFETY AND EFFECTIVENESS SUMMARY portaREM-3000, PFS-6000 NAME OF DEVICE: Rastronics portaREM-3000, Starkey PFS-6000 TYPE OF DEVICE: Hearing aid calibrator and analysis system INTENDED USE: The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other options described in the user manual are available. FEATURES: Easy to use menu-driven software, connections for color monitor and external printer, complete 2cc coupler test according to IEC/ANSI, intermodulation distortion measurement, composite signals, Ear Canal Resonance (REUR), Insertion gain measurements (REIR), In Situ response (REAR), In Situ audiometry, Real Ear 2cc coupler conversion (NAL), Insertion gain with Prescription Rules and Articulation Index, Fitting prescriptions: NAL, POGO I, POGO II, 1/2 Gain, 1/3 Gain, and Berger. There is a 3.5 inch disk drive, built in Thermoprinter for hard copy, test chamber for hearing aid measurement, 4.7" color LCD monitor, battery simulator, two RS-232 serial port interfaces, real ear probe mic. ASSEMBLY: Electronic circuitry all complies to IEC 601 and FCC part 15 class B. Display is 4.7" LCD 640*480 resolution, color monitor, Thermoprinter. Loudspeaker min. 6W in 4 Ohms, freq. range 50 Hz-15,000 Hz. All electrical components are of a standard, off the shelf variety. # TECHNICAL CHARACTERISTICS: Technical specifications complies to IEC 601 and FCC part 15 class B, 2 channels, LCD monitor, Thermoprinter, single 3.5 in floppy drive, measurement circuits freq. range: 42 - 15600 Hz, dynamic range: 130 dB, dynamic resolution: 0.25 dB, accuracy: ±0.2dB, loudspeaker output: min. 6W in 4 Ω, freq. range: 50 - 15000 Hz, electrical THD: < 0.01% MDD compliance will be achieved by Jan. 1997. CONTROLS: The keyboard is a fully functional PC style keyboard. POWER: 110 or 220 V ac; 50-60 Hz; at 220 V AC: 250 mA max., 110 V AC: 500 mA max. 10/28//96 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K964340](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K964340) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com